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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K945118
Device Name EXPIRATORY BREATHING EXERCISER
Applicant
DHD DIEMOLDING HEALTHCARE DIV.
ONE MADISON ST.
WAMPSVILLE,  NY  13163
Applicant Contact JEAN WALLACE
Correspondent
DHD DIEMOLDING HEALTHCARE DIV.
ONE MADISON ST.
WAMPSVILLE,  NY  13163
Correspondent Contact JEAN WALLACE
Regulation Number868.5690
Classification Product Code
BWF  
Date Received10/18/1994
Decision Date 01/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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